Chronic Insomnia
Conditions
Interventions
Sham Acupuncture/Electroacupuncture Group:sham Acupuncture
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 and =65 years, any gender; (2) Meet diagnostic criteria for chronic insomnia in ICSD-3TR and insomnia criteria in "Traditional Chinese Medicine Industry Standard of China" (ZY/T001.1-94); (3) ISI score =21 while taking NBZDs; (4) Received non-benzodiazepine treatment for chronic insomnia >6 months, medication use >50% of time, =3 nights/week in past 2 weeks; (5) Medications used are NBZDs recommended in "Chinese Adult Insomnia Diagnosis and Treatment Guidelines (2023)", dosage not exceeding maximum recommended dose; (6) Self-reported history of =1 failed attempts to discontinue NBZDs; (7) Patient has willingness to reduce NBZDs; (8) No acupuncture treatment in past 6 months; (9) Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: (1) PSG shows AHI =15/hour, and/or PLMS with arousal =15/hour, and/or REM sleep without atonia, and/or dream enactment behavior; (2) Shift work or cross >2 time zones during 2 weeks before screening or study period; (3) Use of anxiolytics, antidepressants, antipsychotics, melatonin or melatonin agonists during 2 weeks before screening or study period; (4) History of alcohol/substance use disorder within 1 year; (5) Severe psychiatric disorders (e.g., bipolar disorder, major depression); (6) Severe cardiovascular, hepatic, renal, hematological or respiratory diseases; uncontrolled infectious diseases; (7) Needle phobia, local infection/inflammation/scarring at acupoints; (8) Pregnancy or lactation; (9) Investigator-deemed ineligibility; (10) Participation in interventional clinical trials within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discontinuation success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Consensus Sleep Diary;Insomnia Severity Index;Pittsburgh Sleep Quality Index (PSQI);Epworth Sleepiness Scale (ESS);Fatigue Severity Scale;Generalized Anxiety Disorder Scale (GAD-7);PHQ-9 Health Questionnaire;Benzodiazepine Withdrawal Scale;Visual Analog Scale for Drug Craving; | — |
Countries
China
Contacts
Public ContactWang Cong
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Outcome results
None listed